Fast 96-Well Background Calibration Plate

GUDID 10190302000765

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302000765
• NIH Device Record Key: 7e24dde2-54a7-4801-9f97-3b75c6f731fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fast 96-Well Background Calibration Plate
• Version Model Number: 4481308
• Company DUNS: 628548377
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302000765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123955

FDA Product Code

• OOI: real time Nucleic acid amplification system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-08-01

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